Doctors are using the device to treat those too ill for open-heart surgery to try and restore normal blood circulation by preventing mitral valve leaks.(Representative Photo)SANTA LLARA, CALIFORNIA: In a sterile room in Menlo Park, California, a technician carefully maneouvers a tiny metal part so that it locks in precisely. She’s assembling a MitraClip, which will eventually be guided by catheter through a vein in the leg and placed in the heart.

Doctors are using the device to treat those too ill for open-heart surgery to try and restore normal blood circulation by preventing mitral valve leaks. The MitraClip is made by the $20 billion drug, device and nutrition giant Abbott.

At Temecula, at a site south of Menlo Park, Abbott makes Absorb, a stent based on polylactic acid. The company says Absorb is a breakthrough because it dissolves in two-three years, meaning fewer complications than with one that doesn’t degrade.

The global devices business — a combination of intricate science, ever-advancing technology and high-precision engineering is worth $390 billion, encompassing a broad list of products, according to advisory firms. The leaders include top multinational companies like Johnson & Johnson while Abbott leads the chase in vascular devices with sales of approximately $3 billion in 2014.

Entry is tough because coming up with new devices is a sophisticated process of product design and development. Also, a sizeable portion of end products is handled manually but finesse comes with relentless work experience on the part of surgeons.

“In the human body, there is a whole set of engineering and quality requirements that you would think of, as against a normal product developed day to day,” said Jamie Jacobs, divisional vice president, global product development, Abbott Vascular.

Among the advanced materials routinely examined are those from the areas of space exploration and specialised defence equipment, all of which need to go through stringent testing for biocompatibility.

The world’s largest drug companies are leaning toward high-end devices to make drugs that work in specific sets of patients. But when it comes to devices that are implanted inside the body for long periods of time, the standards are exacting and the risk threshold is very low. Abbott Vascular has a 1,700-strong workforce that’s engaged in conceptualisation, prototyping and bench testing.

The process is rigorous and regulatory approvals come at “glacial speed,” which means companies have to build reams of patient safety data that address tough questions. For example, although Absorb is approved in over 100 countries, the company filed for approval by the US Food and Drug Administration only last year. Abbott had started work on it in 2003.

Experts said the next step will be a hearing before the FDA Circulatory System Devices Panel, which will then make a non-binding recommendation. If the panel recommendation is positive, approval may be possible in the second half of 2016, according to experts.

That same rigour is reflected in the development of Xience, a drug-eluting stent, which has been studied in more than 100,000 patients. “We have a lot of these breakthrough technologies like Absorb, MitraClip or Libre (an instant glucose monitoring device) and it also brings to us the responsibility to continuously iterate these to get better and better,” Jacobs said.

“We are now studying endpoints that can reduce the symptoms associated with the disease.

We are looking at ensuring that our devices affect the (patient’s) day-today lives and outcomes.” Technological advances can bring lasting health benefits that could reduce costs in the long run.

“If we develop new capabilities to improve the health of people, we can take the cost of healthcare down significantly and they are not going to go back to the hospital with progressing disease,” Jacobs said.

New device development, like drug discovery, is a costly business, so there is a difficult line to walk between paying for research and affordability. “The new solutions have a much higher potential to reduce the overall healthcare costs than just capturing or reducing costs,” he said.

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